Until recently, the agency showed some flexibility in enforcing the tight time frame, usually allowing a several-day grace period as long as the information submitted in response to its questions did not necessitate a significant amount of study by FDA. Now, however, FDA appears to be sticking more rigidly to the 10-day requirement. If the information is not submitted on time, the agency will restart the 120-day review period from the date the requested information is submitted.
Rules & Regs: FDA tough on FCNs
Companies have 10 business days to respond to any FDA questions raised during its review of a food-contact notification.
Dec 31st, 2001